None listed
Conditions
Interventions
Intervention1: Human insulin analog: RapilinTM 30 (30% insulin aspart and 70% insulin aspart protamine
suspension) injection, Manufactured by Gan & Lee Pharmaceuticals, No. 8
Nanfeng West 1st Street
Sponsors
Mankind Pharma Limited, India
Eligibility
Inclusion criteria
Inclusion criteria: 1. Normal healthy human adult male volunteers aged between 18 -45 years (both ages inclusive). 2. Volunteer provided written informed consent and are willing to participate in the study. 3. Volunteer with Body Mass Index of 18.50 to 27.00 Kg/m2 (both inclusive). 4. No evidence of underlying disease during pre-study screening, medical history, physical examination and laboratory investigations done within 21 days prior to commencement of the study. 5. Pre-study screening laboratory tests are either normal or within acceptable limits or are considered by the Investigator to be of no clinical significance with respect to participation in the study. 6. Negative or non-reactive for antibodies to HIV 1 and 2, hepatitis B & C and RPR. 7. Negative test results for alcohol (in urine or in breath), negative urine drugs of abuse test. 8. Non-smoker, non-tobacco (in any form) users; 9. 12 lead ECG recording either normal or within acceptable limits or considered by the Investigator to be of no clinical significance with respect to his participation in the study. 10. Normal or clinically non - significant chest X-ray (PA) taken within 06 months before the day of dosing. 11. Available for the entire study and capable of understanding instructions and communicating with the investigators and clinical study facility staff. 12. Who has not undergone vasectomy, must agree to use condoms, or spermicide to avoid fathering a child during the course of the study and for a period of 07 days after the last dose administration of investigational product. 13. Volunteer having Oral Glucose Tolerance Test (OGTT) results showing within normal or within acceptable limits or as considered by the Investigator to be of no clinical significance with respect to his participation in the study. 14. Volunteer having HbA1c: less than or equal to 5.6%.
Exclusion criteria
Exclusion criteria: 1. Known allergy to Insulin or any component of the formulation and to any other related drug. 2. History or presence of significant cardiovascular, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, musculoskeletal, neurological or psychiatric disease. 3. History/presence of alcohol abuse or drug abuse. 4. History of smoking, even single cigarette, bidis or any other form. 5. History/presence of asthma. 6. History/presence of urticaria or other allergic type reactions after taking any medication. 7. History/presence of clinically significant illness within 04 weeks before the start of the study. 8. History/presence of significant Hypersensitivity to heparin. 9. History of clinically relevant allergy (except for untreated, asymptomatic, seasonal allergies at time of dosing) or any allergic reactions to any drugs. 10. Scheduled for surgery any time during study or within 07 days after study completion. 11. History of difficulty in donating blood. 12. With unsuitable veins for repeated venipuncture. 13. Participation in any other clinical or bioequivalence study or otherwise would have donated in excess of 350 mL of blood in the last 90 days. 14. Consumption of prescription medication or OTC products (including vitamins and natural products) within 14 days prior to dosing in Period 1, including topical medication. 15. Hospitalization within 28 days prior to administration of the study medication. 16. History of difficulty in swallowing. 17. Evidence of skin lesions on forearm of signs of vein puncture on the forearm suggestive of recent donation or participation in clinical trial. 18. With Systolic blood pressure less than 100 mm of Hg or more than 140 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator. 19. With Diastolic blood pressure less than 60 mm of Hg or more than 90 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the Investigator. 20. Use of any insulin product in the past.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative Bioavalability of test and reference productTimepoint: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary objective of this study is to monitor the safety and tolerability of a single dose subcutaneous injection of RapilinTM 30 or NovoMix® 30 when administered in healthy human adult male subjects under fasting conditionTimepoint: Vital signs [blood pressure, pulse rate and temperature measurement by infrared thermometer] and wellbeing will be assessed after dosing at 01.00, 03.00, 06.00 and 13.00 hours in each study period. In addition, at all times, subjects may report side effects spontaneously to the monitoring staff | — |
Countries
India
Contacts
Public ContactDr Vasudev Shenoy
Ecron Acunova Limited
Outcome results
None listed